Contrast-Enhanced Ultrasound vs Conventional US-guided Percutaneous Needle Biopsy for Pancreatic Diseases: Prospective Multicenter Randomized Controlled Trial

February 15, 2023 updated by: xiao-yan xie
According to previous studies, contrast-enhanced ultrasound (CEUS) -guided Core Biopsy(GB) could improve the diagnosis of biopsy in liver and other superficial mass compared to conventional US-GB. The purpose of this randomized trial is to estimate whether CEUS-GB achieve excellent diagnostic value to conventional US-GB in percutaneous biopsy for pancreatic diseases.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

The patients with pancreatic diseases who need receive percutaneous biopsy were randomized with 1:1 ratio into undergo CEUS-GB group and conventional US-GB group.The aims include:

Comparison the diagnostic accuracy rate between CEUS and US group. Comparison the diagnostic specificity, sensitivity and complication rate between CEUS and US group.

Study Type

Interventional

Enrollment (Anticipated)

196

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Fujian
      • Fuzhou, Fujian, China, 350000
        • Fujian Provincial Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age ≥18 years, WHO/ECOG scores <2;
  • Radiographic examination reveal focal pancreatic lesions;
  • No history of local treatment for pancreatic lesions, systemic chemotherapy, targeting, immunotherapy, etc;

  • Normal organ function, including the following criteria:

    1. Routine blood test: Hb≥80 g/L; PLT≥50×109/L;
    2. Coagulation function test: PT<20s.

Exclusion Criteria:

  • The lesions could not be shown by ultrasound and contrast-enhanced ultrasound;
  • Allergic to ultrasound contrast agent;
  • Cardiovascular and cerebrovascular diseases, liver, kidney and lung failure with significant clinical symptoms;
  • History of unexplained bleeding, severe anemia, bleeding tendency or uncorrected coagulopathy;
  • Combined with active infection;
  • Massive ascites;
  • Patients or family members do not agree to enter the study;
  • Pregnant or lactating women;
  • The investigator considers that there are any other factors that may be inappropriate for inclusion or affect the subject's participation in the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CEUS-guided core biopsy group
Diagnostic test: Contrast-enhanced ultrasound-guided core biopsy
Core biopsy was used to collect samples for pancreatic diseases under contrast-enhanced ultrasound-guided.
Active Comparator: US-guided core biopsy group
Diagnostic test: Conventional ultrasound-guided core biopsy
Core biopsy was used to collect samples for pancreatic diseases under conventional ultrasound-guided.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic accuracy rate
Time Frame: 6 month
Diagnostic accuracy rate was defined as the proportion of patients who reached successful diagnosis
6 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

xiao-yan xie

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

March 1, 2023

Primary Completion (Anticipated)

December 1, 2025

Study Completion (Anticipated)

February 1, 2026

Study Registration Dates

First Submitted

February 15, 2023

First Submitted That Met QC Criteria

February 15, 2023

First Posted (Actual)

February 24, 2023

Study Record Updates

Last Update Posted (Actual)

February 24, 2023

Last Update Submitted That Met QC Criteria

February 15, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BZhuang

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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